Port Access Needle 0671934Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741047916), received between Nov 26, 2019 and Jan 26, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Activation Problem

  IT WAS REPORTED THAT THE NURSE REMOVES THE NEEDLE WHILE ENGAGING THE SAFETY. AFTER ASSESSING PATIENT FOR BLEEDING OR ETC, THEY PICK THE NEEDLE/TUBING UP TO PLACE IN SHARPS CONTAINER AND THE SAFETY MECHANISM DIDN'T FULLY BLOCK THE END OF THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178191 ↗
• MalfunctionJan 26, 2026Activation Problem

  IT WAS REPORTED THAT THE NURSE REMOVES THE NEEDLE WHILE ENGAGING THE SAFETY. AFTER ASSESSING PATIENT FOR BLEEDING OR ETC, THEY PICK THE NEEDLE/TUBING UP TO PLACE IN SHARPS CONTAINER AND THE SAFETY MECHANISM DIDN'T FULLY BLOCK THE END OF THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178189 ↗
• MalfunctionOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT WHOSE PORT HAS BEEN ACCESSED SINCE 9/25 AND TODAY THE RN NOTICED THE NEEDLE HAD DE-ACCESSED ITSELF/CAME OUT OF PATIENT WITHOUT THE SAFETY BEING ENGAGED. THE PATIENT IS ORIENTED, DOES NOT MANIPULATE HIS DEVICES OR HAVE ANYTHING GOING ON THAT WOULD HAVE US QUESTION IF HE DID THIS ON HIS OWN. PATIENT MISSED AN UNKNOWN AMOUNT OF TPN DUE TO THE NEEDLE BEING DISLODGED, OTHERWISE, NO APPARENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359760 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WERE 2X 19 GAUGE 0.75IN NEEDLES LEAKING. THE NURSES THEN RE-ACCESSED THE MEDIPORTS WITH THE 1-INCH NEEDLES WITHOUT ISSUE (EVEN THOUGH THE PATIENTS DO NOT NEED THIS SIZE). IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352260 ↗
• MalfunctionOct 21, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE SAFETY MECHANISMS ON 2 DEVICES (OF THE 19-GAUGE NEEDLES) RECENTLY SEEMED TO BE FAULTY/POTENTIALLY CRACKED OR BROKEN. NO FURTHER DETAILS AVAILABLE OR PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352128 ↗
• MalfunctionAug 4, 2025Backflow; Defective Component; Backflow; Defective Component

  IT WAS REPORTED, BLOOD IS GETTING TRAPPED AT THE BIFURCATION SITE ON POWERLOC SAFETY INFUSION SET. DESPITE ATTEMPTING TO FLUSH LINE BEYOND WHAT POLICY STATES SHOULD BE REQUIRED, BLOOD REMAIN TRAPPED IN THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701810 ↗
• MalfunctionFeb 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT WENT HOME WITH A 46-HOUR CHEMOTHERAPY PUMP ON (B)(6) AND REPORTED LEAKING. ON (B)(6) 2023 SOURCE OF LEAK WAS IDENTIFIED FROM PORT CATHETER (TAIL) A VERY TINY CRACK IN TUBING. MD WAS NOTIFIED. THIS WAS A POWER-PORT 19G 0.75IN NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16359683 ↗
• MalfunctionFeb 1, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "THE IV TEAM RECEIVED CALLS FROM THE NURSING FLOORS THAT THE Y SITE ON THIS DEVICE WAS CRACKED AND IS LEAKING WHILE IN THE PATIENT. THE IV TEAM SO FAR HAS HAD TO SWAP OUT 3 DEVICES WHERE THE Y SITE OF THE DEVICE WAS CRACKED." THE NEEDLE WOULD CRACK AND BREAK WHEN ACCESSING THE PORT OF THE PATIENT. ADDITIONAL INFORMATION (B)(6) 2023. IT WAS REPORTED THERE WAS NO IMMEDIATE HARM DONE TO THE PATIENTS. THIS REPORT ADDRESSES THE FIRST PATIENT AND LEAKING DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277727 ↗
• MalfunctionFeb 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "THE IV TEAM RECEIVED CALLS FROM THE NURSING FLOORS THAT THE Y SITE ON THIS DEVICE WAS CRACKED AND IS LEAKING WHILE IN THE PATIENT. THE IV TEAM SO FAR HAS HAD TO SWAP OUT 3 DEVICES WHERE THE Y SITE OF THE DEVICE WAS CRACKED." THE NEEDLE WOULD CRACK AND BREAK WHEN ACCESSING THE PORT OF THE PATIENT. ADDITIONAL INFORMATION 1/23/23. IT WAS REPORTED THERE WAS NO IMMEDIATE HARM DONE TO THE PATIENTS. THIS REPORT ADDRESSES THE THIRD PATIENT AND LEAKING DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277514 ↗
• MalfunctionFeb 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "THE IV TEAM RECEIVED CALLS FROM THE NURSING FLOORS THAT THE Y SITE ON THIS DEVICE WAS CRACKED AND IS LEAKING WHILE IN THE PATIENT. THE IV TEAM SO FAR HAS HAD TO SWAP OUT 3 DEVICES WHERE THE Y SITE OF THE DEVICE WAS CRACKED." THE NEEDLE WOULD CRACK AND BREAK WHEN ACCESSING THE PORT OF THE PATIENT. ADDITIONAL INFORMATION 1/23/23 IT WAS REPORTED THERE WAS NO IMMEDIATE HARM DONE TO THE PATIENTS. THIS REPORT ADDRESSES THE SECOND PATIENT AND LEAKING DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277513 ↗
• MalfunctionJul 19, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY NURSE ¿ON (B)(6) 2022, PATIENT HAD THE DEVICE CONNECTED TO THEM FOR CHEMOTHERAPY AND THE CHEMOTHERAPY ENDED UP LEAKING ALL OVER THE CHEST WALL, NURSE CLEANED UP THE CHEST WALL AND REPORTED THIS ISSUE TO THEIR PHYSICIAN AND THE SITE WAS THEN ASSESSED THE SITE, THE PATIENT RECEIVED THE REST OF THEIR DOSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059097 ↗
• MalfunctionJun 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A DEFECTIVE PORT NEEDLES/TUBING. THE TUBING ATTACHED TO THE NEEDLE IS CRACKED NEAR THE Y-SITE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11932584 ↗
• MalfunctionAug 6, 2020Defective Component; Defective Component

  IT WAS REPORTED THE BARD POWERLOC SWIS Y-SITE CAP WAS LOOSE AND FELL OFF ON ONE PATIENT. IT WAS STATED THIS POSES AN INFECTION RISK AND SAFETY RISK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10373000 ↗
• MalfunctionJul 31, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED RN ACCESSED PATIENT WITH A 19G 3/4IN POWER LOC MEDIPORT NEEDLE. LOT NUMBER ASDRF078. ON INITIAL FLUSH IT STARTING LEAKING FROM Y-SITE CONNECTION. WHEN RN CHECKED IT, THE TUBING DISCONNECTED FROM Y-SITE AREA. RN WAS STILL STERILE. RE-ACCESSED WITH ANOTHER POWER LOC MEDIPORT WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10352733 ↗
• MalfunctionNov 26, 2019Fracture; Fracture

  IT WAS REPORTED THAT A SMALL HOLE WAS FOUND IN THE PIGTAIL ABOVE THE CLAMP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9379392 ↗